- Hepatic: Serum total bilirubin ≤1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is ≤3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5xULN. If patient has known liver metastases, ALT and/or AST ≤5xULN are allowed.

- Patients of childbearing potential must agree to use effective contraception while on study, and for ≥3 months after last treatment.

- Understand and sign written informed consent document. No consent by durable power of attorney.

Exclusion Criteria:

- Second malignancy - unless following curative intent therapy, has been disease free for ≥2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.

- History of ascites or pleural effusions, unless successfully treated.

- Organ transplant, including allogeneic bone marrow transplant.

- Immunosuppressive therapy including:

- Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics);

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